Frequency of h.Pylori in Children With Dyspeptic Symptoms

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05951998
Collaborator
(none)
100
10

Study Details

Study Description

Brief Summary

The current work aim to:

Estimation of prevalence, Estimation of risk factors, Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Helicobacter pylori infection is a common problem in pediatric practice, it's an important cause of gastrointestinal pathology in children and its acquisition is related with poor socioeconomic conditions. H.pylori is a spiral, microaerophilic, gram-negative bacterium with four to six unipolar sheathed flagella.The human stomach, especially the antrum, is the most common reservoir of this agent. American board of orthodontists antibody blood group and Lewis blood-group antigen might expose cases to H. pylori infection, the most likely mode of transmission is fecal-oral or oral-oral. H.pylori infection is predominantly acquired during early childhood .

    The majority of children with are asymptomatic although a percentage of the infected children develop H. pylori associated diseases such as iron deficiency anemia, B12 deficiency, chronic thrombocytopenic purpura. It can manifest with burning pain in the stomach, nausea, loss of appetite, bloating, weight loss.

    Previous studies showed that geographic area, age, race, educational level, sanitation, and socioeconomic status are among the factors that influence the prevalence of H. pylori infection . No gender differences were found in the prevalence of H. pylori infection, while it was much higher among white people.

    The overall prevalence of H. pylori infection in Egyptian school children was 72.38%. There was no significant difference in the prevalence of infection between boys and girls (73.80% vs. 70.34% respectively, or in the independent effect of sex by age. Of school children living in Sohag, 96.7% tested positive for H. pylori, compared with 81.3% of children from Giza and 61.9% from Cairo. Prevalence was also highest among children of low socio-economic class and decreased gradually among children of medium to high socio-economic class.

    In a previous study conducted by Hunt et al., the prevalence of H. pylori was reported to be 48% among 2-4-year-old children in Ethiopia, while in Nigeria and Mexico it was 82% and 43%, respectively, among 5-9-year-old children..

    The endoscopic findings in order of decreasing frequency in the Pediatric group were nodularity (93.0%), mucosal swelling (32.6%), spotty redness (25.6%), diffuse redness (18.6%), atrophy (9.3%), enlarged fold (4.7%), depressive erosion (4.7%), foveolar-hyperplastic polyp (2.3%), patchy redness (2.3%), red streak (2.3%), and raised erosion (2.3%).

    Invasive and non-invasive tests could be used for diagnosis, while the gold standard is a biopsy specimen of gastrointestinal tract.

    Triple therapy is considered to be the standard treatment for children. Proton pump inhibitor combined with two antibiotics has been shown to be very effective in clearing H. pylori from the stomach, it is recommended to treat with amoxicillin, clarithromycin and a proton pump inhibitor for 2 weeks.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Frequency and Risk Factors of H.Pylori Infection in Children Presented by Dyspeptic Symptoms in Assiut University Children Hospital
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Estimation of frequency of H.pylori infection [Baseline]

      2.Estimation of prevalence of H.pylori infection 3.Estimation of risk factors of H.pylori infection 4.Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Children from age of 3 years to age of 18 years.

    • Children presented with chronic or recurrent dyspeptic symptoms(epigastric pain, post prandial fullness, early satiety, bleaching, heart burn ,bloating ,flatulence ,regurgitation ,nausea ,vomiting and/or halitosis) and/or non variceal hematemesis.

    Exclusion Criteria:
    • Children less than 3 years and more than 18 years.

    • Children with variceal hematemesis.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Gamal A Askar, Prof, Assiut University
    • Principal Investigator: Ashraf M Elsaghier, Prof, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariam Samy Fayek, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05951998
    Other Study ID Numbers:
    • H.pylori infection in children
    First Posted:
    Jul 19, 2023
    Last Update Posted:
    Jul 19, 2023
    Last Verified:
    Jul 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 19, 2023